Necessary, but Not Sufficient. The Benefit Concept in the Project Evaluation of Animal Research in the Context of Directive 2010/63/EU

Using animals for research raises ethical concerns that are addressed in project evaluation by weighing expected harm to animals against expected benefit to society. A harm–benefit analysis (HBA) relies on two preconditions: (a) the study protocol is scientifically suitable and (b) the use of (sentient) animals and harm imposed on them are necessary for achieving the study’s aims. The 3Rs (Replace, Reduce and Refine) provide a guiding principle for evaluating whether the use of animals, their number and the harm imposed on them are necessary. A similar guiding principle for evaluating whether a study protocol is scientifically suitable has recently been proposed: the 3Vs principle referring to the three main aspects of scientific validity in animal research (construct, internal and external validity). Here, we analyse the internal consistency and compatibility of these two principles, address conflicts within and between the 3Rs and 3Vs principles and discuss their implications for project evaluation. We show that a few conflicts and trade-offs exist, but that these can be resolved either by appropriate study designs or by ethical deliberation in the HBA. In combination, the 3Vs, 3Rs and the HBA thus offer a coherent framework for a logically structured evaluation procedure to decide about the legitimacy of animal research projects.

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Approaches to animal research project evaluation in Europe after implementation of Directive 2010/63/EU

Lab Animal ◽

10.1038/laban.604 ◽

2014 ◽

Vol 44 (1) ◽

pp. 23-31 ◽

Cited By ~ 5

Author(s):

Javier Guillén ◽

Sally Robinson ◽

Thierry Decelle ◽

Cornelia Exner ◽

Martje Fentener van Vlissingen

Keyword(s):

Project Evaluation ◽

Animal Research ◽

Research Project

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44. How to tip the Harm-Benefit-Scales in gene editing – and why legal regulations always trump personal and public beliefs in project evaluation in animal research

Sustainable governance and management of food systems ◽

10.3920/978-90-8686-892-6_44 ◽

2019 ◽

Author(s):

M. Eggel ◽

H. Grimm

Keyword(s):

Gene Editing ◽

Project Evaluation ◽

Animal Research ◽

Legal Regulations ◽

Public Beliefs

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Effect of percentage cut-off scores and scale point variation on preclinical project evaluation

Journal of Dental Education ◽

10.1002/j.0022-0337.1983.47.10.tb01717.x ◽

1983 ◽

Vol 47 (10) ◽

pp. 650-655 ◽

Cited By ~ 1

Author(s):

NJ Deranleau ◽

JH Feiker ◽

M Beck

Keyword(s):

Project Evaluation ◽

Scale Point

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Evaluation of the vestibular system in experimental animal research: morphology and electrophysiology

Clinical Otolaryngology ◽

10.1046/j.1365-2273.2000.00358-22.x ◽

2000 ◽

Vol 25 (4) ◽

pp. 328-328

Author(s):

M.L.Y.M. Oei ◽

J.M. Segenhout ◽

F. Dijk ◽

H.P. Wit ◽

F.W.J. Albers

Keyword(s):

Experimental Animal ◽

Vestibular System ◽

Animal Research

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Animal Ethics in Animal Research

10.1017/9781108354882 ◽

2017 ◽

Cited By ~ 2

Author(s):

Helena Rocklinsberg ◽

Mickey Gjerris ◽

Anna Olsson

Keyword(s):

Animal Ethics ◽

Animal Research

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Self-Injurious Behavior vs. Nonsuicidal Self-Injury

Crisis ◽

10.1027/0227-5910/a000127 ◽

2012 ◽

Vol 33 (2) ◽

pp. 106-112 ◽

Cited By ~ 3

Author(s):

Christopher M. Bloom ◽

Shareen Holly ◽

Adam M. P. Miller

Keyword(s):

Positive Reinforcement ◽

Empirical Investigation ◽

High Stress ◽

Animal Research ◽

Stress Conditions ◽

Human Populations ◽

Pharmacological Interventions ◽

Self Injury ◽

Cns Stimulant ◽

Nonsuicidal Self Injury

Background: Historically, the field of self-injury has distinguished between the behaviors exhibited among individuals with a developmental disability (self-injurious behaviors; SIB) and those present within a normative population (nonsuicidal self-injury; NSSI),which typically result as a response to perceived stress. More recently, however, conclusions about NSSI have been drawn from lines of animal research aimed at examining the neurobiological mechanisms of SIB. Despite some functional similarity between SIB and NSSI, no empirical investigation has provided precedent for the application of SIB-targeted animal research as justification for pharmacological interventions in populations demonstrating NSSI. Aims: The present study examined this question directly, by simulating an animal model of SIB in rodents injected with pemoline and systematically manipulating stress conditions in order to monitor rates of self-injury. Methods: Sham controls and experimental animals injected with pemoline (200 mg/kg) were assigned to either a low stress (discriminated positive reinforcement) or high stress (discriminated avoidance) group and compared on the dependent measures of self-inflicted injury prevalence and severity. Results: The manipulation of stress conditions did not impact the rate of self-injury demonstrated by the rats. The results do not support a model of stress-induced SIB in rodents. Conclusions: Current findings provide evidence for caution in the development of pharmacotherapies of NSSI in human populations based on CNS stimulant models. Theoretical implications are discussed with respect to antecedent factors such as preinjury arousal level and environmental stress.

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